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July 2005 News Archive Guidant Announces New Safety Concerns Posted by Mark Guidant Corporation said today it is voluntarily advising physicians about important safety information regarding certain devices. Guidant apprised FDA of this action, and FDA may classify this action as a recall. This communication advises physicians and their patients of safety information and is intended to limit adverse events. Physicians should use this information to decide how best to treat their patients. A subset of the following devices manufactured between November 25, 1997 and October 26, 2000 are impacted: PULSAR® MAX, PULSAR, DISCOVERY®, MERIDIAN®, PULSAR MAX II, DISCOVERY II, VIRTUS PLUS® II, INTELIS II, CONTAK® TR These products, which are of an earlier generation design, have not been sold or implanted for the last four years. Guidant has determined that a hermetic sealing component used in the subset of devices listed above may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case late in the device’s service life. As of July 11, 2005, Guidant has identified sixty-nine (69) devices that may have exhibited this failure mode from approximately 78,000 devices distributed with this component. While no failures have been reported prior to 44 months of service, the likelihood of occurrence increases with implant time. Guidant’s modeling based on field experience and statistical life-table analysis predicts the rate of failure in the remaining active implanted devices to be between 0.17% and 0.51% over the remaining device lifetime. Of the 78,000 devices originally distributed, approximately 28,000 devices remain implanted worldwide; 18,000 of these devices remain in service in the United States with an average implant age of 69 months... Read the full article. Source: Guidant.com The contents of the Long-QT-Syndrome.com Site, such as text, graphics, images and all other material contained on Long-QT-Syndrome.com are for informational purposes only. The contents were not written by a practicing medical doctor/physician and may not be correct. The content within Long-QT-Syndrome.com is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on the Long-QT-Syndrome.com Site! |
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